Claims Based on Chronic Effects of Exposure to Vesicant Agents

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AG29

Claims Based on Chronic Effects of Exposure to Vesicant Agents

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend

its adjudication regulations concerning compensation for disabilities

or deaths resulting from the chronic effects of in-service exposure to

mustard gas and other vesicant agents. This proposed regulation is

based on a National Academy of Sciences (NAS) study of the long-term

health effects of exposure to vesicant agents, commissioned by VA,

which found a relationship between such exposure and the subsequent

development of certain conditions. The intended effect of this proposed

amendment is to expand and extend compensation eligibility.

DATES: Comments must be received on or before March 25, 1994. Comments

will be available for public inspection until April 4, 1994. This

amendment is proposed to be effective the date of publication of the

final rule.

ADDRESSES: Interested persons are invited to submit written comments,

suggestions, or objections regarding this amendment to Secretary of

Veterans Affairs (271A), Department of Veterans Affairs, 810 Vermont

Avenue, NW., Washington, DC 20420. All written comments received will

be available for public inspection only in the Veterans Services Unit,

room 170, at the above address between the hours of 8 a.m. and 4:30

p.m., Monday through Friday (except holidays), until April 4, 1994.

FOR FURTHER INFORMATION CONTACT: John Bisset, Jr., Consultant,

Regulations Staff, Compensation and Pension Service, Veterans Benefits

Administration, (202) 233-3005.

SUPPLEMENTARY INFORMATION: On July 31, 1992, VA published a final

regulation (38 CFR 3.316) authorizing service connection in claims from

veterans who underwent full-body exposure to mustard gas during field

or chamber experiments to test protective clothing or equipment during

World War II, and who subsequently develop chronic forms of laryngitis,

bronchitis, emphysema, asthma, conjunctivitis, keratitis, or corneal

opacities (See 57 FR 1699-1700 and 57 FR 33875-77). The regulation was

based on a review of the available English language medical literature

dealing with the effects of exposure to mustard gas by Veterans Health

Administration (VHA) personnel. VA also contracted with NAS to conduct

a review of the world medical and scientific literature, including that

published in languages other than English, to determine the long-term

health effects of exposure to mustard agents and Lewisite. After

reviewing almost 2,000 medical and scientific papers, consulting with

outside experts, and conducting public hearings, NAS issued that

report, entitled ``Veterans at Risk: The Health Effects of Mustard Gas

and Lewisite'', on January 6, 1993. We are proposing to amend 38 CFR

3.316 based upon our review of that report.

NAS findings confirmed VA's prior determination that there is a

relationship between exposure to mustard gas and the subsequent

development of the seven conditions previously mentioned. NAS also

found that the evidence indicated a causal relationship between

exposure to mustard gas and the subsequent development of ``recurrent

corneal ulcerative disease'' and ``delayed recurrent keratitis of the

eye.'' In our judgment the term ``corneal opacities,'' used in the

current regulation, is broad enough to include corneal ulcerative

disease and we do not propose to change the language in the current

regulation. For reasons discussed below, this regulation will cover

specified conditions whether onset occurred immediately after exposure

or was delayed, and we find no reason to modify the term ``keratitis''

which appears in the current regulation.

NAS also found that the evidence indicated a causal relationship

between exposure to mustard gas and the subsequent development of

nasopharyngeal, laryngeal, lung, and skin cancers, pigmentation

abnormalities of the skin, and chronic skin ulceration and scar

formation. We propose to add nasopharyngeal, laryngeal and lung cancer

(except mesothelioma) to the list of conditions for which presumptive

service connection may be granted based on exposure to mustard gas. We

are proposing to exclude mesothelioma from the regulatory amendment,

however, since the only known cause of that condition is asbestos

exposure.

Although NAS used the term ``skin cancer'' in the summary of its

findings, in our judgment the body of the report, which refers to

squamous cell and basal cell carcinomas of the skin but not malignant

melanomas, does not support so broad a presumption of service

connection. Although basal cell skin cancers were noted in some animal

studies, these studies constitute evidence of carcinogenicity rather

than evidence of skin cancer because there is no good animal model for

human skin response to mustard agents. Likewise, the one occupational

study that described basal cell carcinomas, Bowen's disease, and other

hyperkeratotic skin lesions was too seriously flawed to establish a

causal relationship with exposure to mustard agents. As the report

notes, the workers in that study were exposed to all types of gases,

not just mustard gas and Lewisite. Also, those individuals who

participated in chamber and field testing suffered acute rather than

chronic exposure like the chemical plant workers in the occupational

study, which occurred for many hours each week over many years. The

report states that ``cutaneous cancers following acute sulfur mustard

exposure usually localize in scars,'' and scar cancers are squamous

cell carcinomas, not basal cell carcinomas. Finally, since the 1973

Jackson and Adams study, which is cited in the NAS report in reference

to the occurrence of basal cell carcinoma and which included two cases

of basal cell carcinomas in World War I veterans, is not an

epidemiologic study, it is difficult to draw conclusions as to whether

the findings represent an unusual rate for basal cell carcinoma. For

these reasons, we propose to include only squamous cell carcinomas of

the skin.

In our judgment, there is no reason to establish presumptive

service connection for ``pigmentation abnormalities of the skin''

because these abnormalities would be obvious from the time of the

exposure to vesicant agents rather than occurring many years after

exposure, as in the case of cancer. Also, because the usual places for

mustard gas burns are areas of the body which are not visible, i.e.,

moist areas of the body such as the groin and axilla, rather than

exposed areas as in the case of sunburn, most pigmentation

abnormalities resulting from these burns would not be considered

disabling, unless they interfered with the veteran's ability to

function. In this regard, there is no mention in the NAS report of

vitiligo-type lesions, which are usually considered to be disabling

because they are disfiguring. Since compensation is only payable for a

disability resulting from an injury suffered or disease contracted in

line of duty or from aggravation of a preexisting injury or disease

contracted in line of duty (See 38 U.S.C. 1110, 1121, 1131, and 1310),

and since exposure to vesicant agents does not cause a type of

pigmentation abnormality which is disabling, we do not propose to

include pigmentation abnormalities of the skin in the regulation.

However, we propose to include scar formation in the regulation.

In addition to the respiratory conditions VA had previously

recognized, NAS found that the evidence indicated a causal relationship

between exposure to mustard gas and chronic obstructive pulmonary

disease. NAS further found that all these respiratory conditions could

also result from exposure to Lewisite, another vesicant agent. We are

proposing to provide service connection for a chronic form of

laryngitis, bronchitis, emphysema, asthma or chronic obstructive

pulmonary disease, as a result of exposure to mustard gas or Lewisite.

Additionally, NAS determined that the evidence indicated a causal

relationship exists between exposure to nitrogen mustard and the

subsequent development of acute nonlymphocytic leukemia. Based on that

information, we propose to provide service connection for acute

nonlymphocytic leukemia as a result of exposure to nitrogen mustard

only.

NAS also found evidence that indicates a causal relationship

between mustard gas exposure and the subsequent development of bone

marrow depression, immunosuppression, psychological disorders, and

sexual dysfunction, but we do not propose to allow presumptive service

connection for these conditions. Bone marrow depression and

immunosuppression are acute effects that may have resulted in greater

susceptibility to infections with a possibility of damage to vital

organ systems. Since these acute effects would have resolved within a

relatively short period, however, any related infection would have

occurred in service or shortly thereafter and an adequate regulatory

framework to establish direct service connection already exists.

Psychological disorders may result from traumatic or stressful features

of the exposure experience, but are not a toxic effect of the agents

themselves. An adequate regulatory framework currently exists to

establish service connection for post-traumatic stress disorder as a

result of exposure to vesicant agents. Establishing a presumption of

service connection for sexual dysfunction would serve no purpose, since

sexual dysfunction is not compensated under VA's Schedule for Rating

Disabilities (38 CFR Part 4) but rather under 38 U.S.C. 1114(k), which

provides special monthly compensation for the loss or loss of use of a

creative organ. Special monthly compensation is a benefit established

by Congress, not by VA regulation, and is therefore beyond the scope of

this rulemaking.

There were two other categories of findings in the NAS report. NAS

found that the evidence was ``suggestive'' of a causal relationship

between exposure to mustard gas and reproductive dysfunction

(genotoxicity, mutagenicity, etc.) and exposure to sulfur mustard and

leukemia. NAS found insufficient evidence of a causal relationship

between exposure to mustard gas and gastrointestinal diseases,

hematologic diseases, neurological diseases, cardiovascular diseases,

and for reproductive dysfunction as a result of exposure to Lewisite.

As NAS itself indicates, further study in these areas is necessary and

in our judgment, the scientific and medical evidence on the whole does

not support the establishment of presumptions for these conditions.

Since the revised regulation will address the effects of Lewisite

as well as mustard agents, we propose to revise the heading of 38 CFR

3.316 to indicate that the regulation addresses claims based on chronic

effects of exposure to vesicant agents rather than mustard gas only.

The current regulation applies only to those veterans exposed while

participating in secret tests of protective equipment during World War

II; we propose to expand it to cover any verified full-body exposure

during military service, which will allow veterans exposed to mustard

gas under battlefield conditions in World War I, those present at the

German air raid on the harbor of Bari, Italy, in World War II, and

those engaged in manufacturing and handling vesicant agents during

their military service to be eligible for consideration under this

regulation.

We are not proposing to include veterans who were exposed to

vesicant agents via patch or drop testing. The literature upon which

the NAS report is based covered animal studies and two types of human

studies: (1) Industrial studies of workers in chemical factories which

manufactured mustard gas; and (2) studies of soldiers exposed to

mustard gas in warfare, primarily during World War I. These studies

involved full-body exposure, not patch testing. The NAS report does not

discuss any studies relevant to patch or drop testing. However, the NAS

report concluded that the exposure of many participants in chamber and

field tests was equivalent to that of soldiers in World War I, and

therefore the NAS report concluded that the World War I and chronic

exposure studies were relevant to the experience in the chamber and

field tests. Since the NAS report only considered studies involving

full-body exposure, we believe that the NAS findings regarding specific

diseases are linked only to full-body exposure, and not to patch or

drop testing.

We also propose to amend 38 CFR 3.316 by adding a requirement that

service connection will not be established if there is affirmative

evidence that establishes a nonservice-related supervening condition or

event as the cause of the claimed condition. The current regulation is

based upon a literature search of the immediate and short-term effects

of mustard gas exposure by the Veterans Health Administration, which

revealed that nonfatal exposures to mustard gas result in an immediate

acute injury. It was also reported that any chronic disability related

to mustard gas exposure should appear shortly after the exposure and

continue to the present. The NAS report, however, found that delayed

effects of mustard gas exposure may appear even though no acute effects

were noted. Because of this delay in manifestation of effects of

mustard gas exposure reported by the NAS, during which time the veteran

may have been exposed to other nonservice-related causative conditions

or events, we have determined that it is reasonable to consider

evidence of intervening cause which may exist, just as we do for other

presumptive conditions (See 38 CFR 3.307(b)).

The Secretary hereby certifies that this regulatory amendment will

not have a significant economic impact on a substantial number of small

entities as they are defined in the Regulatory Flexibility Act (RFA), 5

U.S.C. 601-612. The reason for this certification is that this

amendment would not directly affect any small entities. Only VA

beneficiaries could be directly affected. Therefore, pursuant to 5

U.S.C. 605(b), this amendment is exempt from the initial and final

regulatory flexibility analysis requirements of sections 603 and 604.

(The Catalog of Federal Domestic Assistance program numbers are

64.109 and 64.110.)

List of Subjects in 38 CFR Part 3

Administrative practice and procedure, Claims, Handicapped, Health

care, Pensions, Veterans.

Approved October 22, 1993.

Jesse Brown,

Secretary of Veterans Affairs.

For the reasons set out in the preamble, 38 CFR part 3 is proposed

to be amended as set forth below:

PART 3--ADJUDICATION

Subpart A--Pension, Compensation, and Dependency and Indemnity

Compensation

1. The authority citation for part 3, subpart A, continues to read

as follows:

Authority: 38 U.S.C. 501(a), unless otherwise noted.

2. 38 CFR 3.316 is revised to read as follows:

Sec. 3.316 Claims based on chronic effects of exposure to vesicant

agents.

(a) Except as provided in paragraph (b) of this section, exposure

to the specified vesicant agents during active military service under

the circumstances described below in paragraphs (a)(1) through (3) of

this section together with the subsequent development of any of the

indicated conditions is sufficient to establish service connection for

that condition:

(1) Any verified full-body exposure to nitrogen or sulfur mustard

during active military service together with the subsequent development

of chronic conjunctivitis, keratitis, corneal opacities, scar

formation, or the following cancers: nasopharyngeal; laryngeal; lung

(except mesothelioma); or, squamous cell carcinoma of the skin.

(2) Any verified full-body exposure to nitrogen or sulfur mustard

or Lewisite during active military service together with the subsequent

development of a chronic form of laryngitis, bronchitis, emphysema,

asthma or chronic obstructive pulmonary disease.

(3) Any verified full-body exposure to nitrogen mustard during

active military service together with the subsequent development of

acute nonlymphocytic leukemia.

(b) Service connection will not be established under this section

if the claimed condition is due to the veteran's own willful misconduct

(See Sec. 3.301(c)) or there is affirmative evidence that establishes a

nonservice-related supervening condition or event as the cause of the

claimed condition (See Sec. 303).

[FR Doc. 94-1484 Filed 1-21-94; 10:00 a.m.]

BILLING CODE 8320-01-M